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BPH and LUTS: Interpreting Clinical Data on Saw Palmetto Extracts


Expert insight on clinical trial data informing the use of saw palmetto extracts in benign prostatic hyperplasia and lower urinary tract symptoms.


Bilal Chughtai, MD: When it comes to the clinical data with saw palmetto, there have been extensive meta-analyses and Cochran reviews trying to understand exactly where the role is for saw palmetto. Unfortunately, when it comes to a lot of the studies for saw palmetto, including CAMUS and STEP, one problem is that there wasn’t a complete standardization of what compound was used. The question also becomes, in CAMUS and STEP, would the saw palmetto that was used meet the USP [US Pharmacopeia] criteria today? Sometimes, you have to look at the data with a grain of salt

The second thing about these supplement studies is the absence of clear-cut entry criteria and exactly how patients fell off. A lot of times you were having patients with sometimes moderate to severe lower urinary tract symptoms combined with those with mild to moderate symptoms. Ultimately, when you take a very heterogeneous group, a lot of times you lose signals, making it hard to determine exactly how this compound would be helpful. When it comes to the clinical trial data as a whole, unfortunately, the data have been mixed. It’s partially because you have a supplement that isn’t well regulated or standardized. Additionally, some of the studies were quite heterogeneous as well.

When it comes to Permixon and the European data that goes with it, the ability to help lower urinary tract symptoms secondary to BPH [benign prostatic hyperplasia] looks very promising. Some of the data, especially for Permixon, does rival that of alpha blockers and PDE5 [phosphodiesterase-5] inhibitors. Now, some of these trials have very carefully selected populations. Therefore, there may be a very clear-cut role in clinical benefit for Permixon in the properly selected patient.

When you look at the data for Permixon, we can see that it’s got a very gradual onset of action. I think in a carefully selected population, what I would define as the mild BPH group, patients will do quite well with a compound like Permixon. These are usually patients that aren’t looking for active medical treatment. They still require them to be monitored and ensure that there isn’t significant progression of their condition, but ultimately that group can do fairly well with Permixon for a long time. What’s even more notable about saw palmetto as a whole is that in the CAMUS trial, part of that was a dose-finding study, and even a 3XD [3 times appropriate dose] for saw palmetto showed exquisite safety, even at very high doses.

Transcript edited for clarity.

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